Survey Details ( pre 2/2/2009)

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1. Anonymized

2.
(1)*Redacted* Pharmaceuticals USA
(2)Regulatory Affairs - Labeling Unit
(3)Regulatory

5.
(1) 3
(2) 4
(3) 1
(4) 90
(5) 6
Average 20.8 (104/5)

8. One group Regulatory Person, Two groups Labeling people

9. Two groups will be Regulatory person, one group will remain labeling people

13. Call D&B

15.
US
(1) 1
(2) 1
(3) 1
(4) 8
Average 3.75 (11/4)

Foreign
(1) 4
(2) 8
(3) 4
(4) 4
Average 5 (20/4)

19. Administrative Assistant in Technical Operations

24.
(1) Call D&B
(2) Contact directly as well

29. One group RA, two groups labeling people

30. Two groups RA, one grou labeling

33. spl working group, not wiki

35. Expected date of first Labeler Code Request SPL submission
(1) 2/15/2009
(2) 2/15/2009

Expected date of first Establishment Registration SPL submission
(1) 2/20/2009
(2) 2/15/2009

Expected date of first Product Listing/Content of Labeling SPL submission
(1) 3/01/2009
(2) 05/15/2009

36. N/A

40. Answers 1&2. 1 for two labeling groups, 2 for one labeling group

41. 2, 3 & 4

43.
(1) Working these details out now
(2) X-Forms
(3) Add new users to an exiting system that will be upgraded to meet the SPLr4 requirements

44. Anonymized